NCT05519735 Lymphatic Organs and Myocardium After Myocardial Infarction
| NCT ID | NCT05519735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wuerzburg University Hospital |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 57 participants in total. It began in 2022-04-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. However, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. Multimodal imaging of the heart and immunologic organs might provide such information. Recent retrospective analysis of patients after MI revealed enlarged mediastinal lymph nodes associated with increased CXCR4 radiotracer accumulation, thereby indicating that CXCR4 PET-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. These considerations are further fuelled by the fact that, within lymph nodes, CXCR4 is expressed almost exclusively on lymphocytes, whereas various other cell types express CXCR4 within the myocardium. This leads to the hypothesis that the size of mediastinal lymph nodes and their respective CXCR4 PET signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up. This prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (CXCR4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute MI. The combination of cardiac magnetic resonance (CMR), echocardiography, and positron emission tomography (PET) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective PET-derived CXCR4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.
Eligibility Criteria
Inclusion Criteria: * patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization * stable clinical course * male/female, above 18 years old Exclusion Criteria: * hemodynamic instablity \> 48 h after immediate catherization * known CAD * known structural heart disease * multi vessel disease * NSTEMI * sarcoidosis * immunosuppressive therapy * acute inflammatory disease * no consent obtainable * contraindiations for CMR * impaired renal function * active cardiac implants, ferromagnetic implants * pregnancy, breast-feeding
Contact & Investigator
Theresa Reiter, MD
PRINCIPAL INVESTIGATOR
Wuerzburg University Hospital
Frequently Asked Questions
Who can join the NCT05519735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05519735 currently recruiting?
Yes, NCT05519735 is actively recruiting participants. Contact the research team at reiter_t@ukw.de for enrollment information.
Where is the NCT05519735 trial being conducted?
This trial is being conducted at Würzburg, Germany, Würzburg, Germany.
Who is sponsoring the NCT05519735 clinical trial?
NCT05519735 is sponsored by Wuerzburg University Hospital. The principal investigator is Theresa Reiter, MD at Wuerzburg University Hospital. The trial plans to enroll 57 participants.